NCT07208890

Methotrexate Iontophoresis Versus Methotrexate 1% Gel on Depigmentation in Vitiligo Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Pharos University in Alexandria · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Vitiligo is a common autoimmune depigmenting disorder characterized by selective destruction of melanocytes. Methotrexate (MTX) has shown potential in stabilizing disease activity and promoting repigmentation; however, systemic administration may cause hepatotoxicity. This pilot study aims to compare the efficacy and safety of methotrexate iontophoresis versus topical methotrexate 1% gel in patients with vitiligo. Thirty patients will be randomly assigned into two equal groups: Group A will receive methotrexate iontophoresis (5-10 mA, 15 min/session) for 8 weeks, while Group B will apply methotrexate 1% gel twice daily for 8 weeks. Outcomes will be assessed using the Vitiligo Area and Severity Index (VASI) and the Vitiligo Impact Scale-22 (VIS-22), with liver function monitored monthly

Detailed description

Vitiligo is an autoimmune depigmenting disorder characterized by melanocyte destruction. Methotrexate (MTX) has shown potential in modulating autoimmune activity and promoting repigmentation, but systemic use carries hepatotoxic risks. This pilot randomized study compares methotrexate iontophoresis and topical methotrexate 1% gel in stable vitiligo patients. Thirty participants will be assigned equally into two groups: the iontophoresis group will receive MTX via low-intensity electric current sessions for 8 weeks, while the control group will apply topical MTX gel twice daily for the same period. Efficacy will be evaluated using the Vitiligo Area and Severity Index (VASI) and quality of life by the Vitiligo Impact Scale-22 (VIS-22). Liver function will be monitored monthly to ensure safety

Conditions

• Vitiligo - Evaluation of Methotrexate Iontophoresis and Topical Methotrexate Gel as Localized Treatment Approache

Interventions

Type	Name	Description
DEVICE	Methotrexate Iontophoresis/a low-intensity electric current	: Application of methotrexate solution via iontophoresis using a low-intensity electric current (5-10 mA) for 15 minutes per session, once weekly for 4 weeks, then biweekly for another 4 weeks

Timeline

• Start date: 2025-11-10
• Primary completion: 2026-02-10
• Completion: 2026-03-10
• First posted: 2025-10-06
• Last updated: 2025-10-06